Efficacy and safety of insulin glargine 300 units/mL vs insulin glargine 100 units/mL in adult patients with type 1 diabetes

This article compared the safety and effectiveness of insulin glargine (Lantus) at two different doses in the management of type 1 diabetes (T1D). The authors concluded that the effectiveness and safety of both doses were similar. 

In T1D the body does not make insulin and cannot lower the blood glucose. Therefore, patients have to get insulin from an injection in order to lower blood glucose. Insulin glargine (IGla) is a long-acting form of insulin which lowers the blood glucose. Measuring HbA1c (how much glucose is on the red blood cells) allows saying how well diabetes is controlled. However, it does not fully explain glycaemic variability (swings in blood glucose levels from high to low).

An alternative is to carry out continuous glucose monitoring. This is known as time in range (TIR; the amount of time in a 24 hr period when glucose is within the adequate ranges, 70-180mh/dl). Reducing large changes in blood glucose is becoming more important. It is important to research which morning dose of IGla is more effective in maintaining blood glucose within the range more time during the day.

This study involved 638 patients with T1DM. They were randomly assigned to two groups. Group 1 received morning IGla injections 300 u/mL (320). Group 2 received IGla injections 100 u/mL (318). The study lasted for 16 weeks. 

At the end of the 16 weeks, there was no difference between the two groups regarding TIR, glycaemic variability or nocturnal hypoglycemia (blood glucose going dangerously low). 

In patients with HbA1c levels of less than 7.5% at the end of 16 weeks, group 1 had an improved TIR compared with patients in group 2. This came with a small increase in hypoglycemia rates.

The authors concluded that both 300 u/mL and 100 u/mL doses of IGla were of similar effectiveness and safety in patients with T1D. 

This study was not masked to the patients. This might have influenced the results.